BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECMO OXYGENATOR

    MDR report key: 690403 · Received March 17, 2006

    Report

    Report Number
    2184009-2006-00022
    Event Type
    Malfunction
    Date Received
    March 17, 2006
    Date of Event
    February 16, 2006
    Report Date
    February 17, 2006
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LEAK WAS DETECTED FROM THE GAS OUTLET PORT OT HTE DEVICE DURING ECMO SUPPORT AFTER APPROXIMATELY 4-6 HOURS SERVICE LIFE. THE UNIT WAS REPLACED DURING THE CASE WITH NO PATIENT COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECMO OXYGENATOR SILICONE MEMBRANE OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 0800 0409001528

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention